As devices get smaller, making implant surgery simpler for the physician, the one constant that must remain if the device is to deliver its lifesaving or enhancing function, is its reliability

The manufacture of medical implantable devices are highly regulated by regulatory bodies such as the International Standards Organization (ISO) and the US Food and Drug Administration (FDA) to maintain the highest level of reliability. The tight controls placed on the design, development and manufacture of these devices must be met by the suppliers of the component parts.

Meeting the Reliability Challenge

In alignment with these exacting regulatory requirements the operational processes, testing and quality assurance provided by Knowles Precision Devices is tightly controlled. We work closely with medical device innovators to create source control drawings (SCD) governing every aspect of the capacitors we supply. SCD’s provide an engineering description, qualifications and acceptance criteria for the delivery of specialized components for critical applications.

The two main SCD specifications for medical components are MIL-PRF-55681 and MIL-PRF-123

MIL-PRF-55681 is the one most widely used in the field of medical implantable devices. It defines a mid-K stable dielectric designated as BX.

The MIL-PRF-123 specification covers the general requirements for high reliability, general purpose (BX and BR) and temperature stable (BP and BG) ceramic dielectric fixed capacitors, through-hole and SMD and affords an increased reliability level over MIL-PRF-55681.